Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids.

This study has been completed.
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00727909
First received: July 30, 2008
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

This study is being conducted to evaluate the benefits of in-the-ear vs. open-fit behind-the-ear hearing aids. We want to learn more about which patients prefer each type, so we can make better choices about which type of hearing aid is best for which patients. Participants in this study will try three different sets of hearing aids for 2 months each, then we will evaluate the benefit of each type. Participants must be Veterans who are eligible for audiology care at one of the three participating sites.


Condition Intervention
Hearing Loss
Device: In-the-ear hearing aids
Device: Behind-the-ear hearing aids, receiver-in-the canal
Device: Behind-the-ear hearing aids, receiver-in-the-hearing aid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Open-Ear Canal and Traditional Custom-Fit Hearing Aids

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Patient subjective ranking of the three types of hearing aids [ Time Frame: At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each) ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Hearing aid fitting, 3 different types
Device: In-the-ear hearing aids
Traditional custom fit in-the-ear hearing aid
Device: Behind-the-ear hearing aids, receiver-in-the canal
Open fit non-custom, behind-the-ear hearing aid with receiver in the ear canal.
Device: Behind-the-ear hearing aids, receiver-in-the-hearing aid
Open fit non-custom, behind-the-ear hearing aids with receiver in the hearing aid.

Detailed Description:

Hearing loss is the most common service-connected disability nationwide in the VHA system, with hearing aids providing the primary treatment option. Although the benefits of hearing-aid use are clearly established,~16-30% of adults who have hearing aids do not use them. Several factors are believed to result in non-use of traditional hearing aids, including (1) poor fit and comfort, (2) poor cosmetics, (3) whistling feedback, (4) occlusion, and (5) difficulty understanding speech in noise.

Recently, the open canal (OC) hearing-aid style has become a viable approach to addressing address many of the problems resulting in non-use of traditional hearing aids, particularly for individuals with mild to moderately-severe hearing loss. Although an OC hearing aid has many potential advantages, there also are potential limitations. For example, the maximum low and high-frequency gain available with an OC fitting is less than that available from traditional custom (TC) hearing-aid fittings, which could result in less than optimal amplification for some individuals. In addition, directional microphone benefits for speech understanding in noise, available with TC fittings, likely will be limited with OC fittings due to the loss of low-frequency gain (Ricketts et al., 2005).

Since both OC and TC fittings are appropriate for listeners with mild to moderately-severe hearing losses, evidence is needed to determine which style of hearing aid is preferred by a majority. Currently, OC fittings use a small behind-the-ear (BTE) hearing aid coupled to a thin tube or plastic covered wire ending in a vented "open" eartip. When a TC fitting is used with patients with similar hearing losses, the majority are either an in-the-ear (ITE) or in-the-canal (ITC) .In the proposed study a comparison will be made between OC vs. TC fittings.. In addition to this primary comparison, preference for one of two OC hearing aids, viz., OC instruments with receiver in the ear (OCRITE) and the OC instruments with receiver in the hearing-aid case (OCRIHA), will be determined. The outcomes of the OCRITE, OCRIHA, and TC hearing-aid use related to the factors of: (1) comfort and cosmetics, (2) subjective occlusion, (3) objective occlusion, (4) sound quality for external sounds, (5) feedback, (6) ease of use, (7) audibility, (8) aided signal-to-noise ratio (SNR) benefit, and (9) localization, will be measured in a large (n = 288), randomized-controlled, three-site (Bay Pines, Mountain Home, and Nashville) clinical trial, utilizing a three-period (two months each), cross-over design. A total of 13 variables will be measured for the 9 hearing-aid fitting and style-related factors. At the end of the study, participants will rank order their preferences for the three hearing aid fittings to determine (1) the preferred OC fitting (OCRITE vs. OCRIHA) and (2) whether the highest ranked OC fitting or the TC fitting is preferred. Preferred OC vs. TC difference scores will be calculated for all relevant variables. The ability of the differences scores to predict the preferences of the participants for an OC vs. TC hearing aid will be determined, in order to develop an evidence-based hearing aid selection model.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sensorineural hearing loss
  • Veteran-adult onset of hearing
  • English as first language
  • Eligible for VA issued hearing aids
  • Eligible to receive care at one of the three participating VA sites: Nashville, Mountain Home TN, Bay Pines FL

Exclusion Criteria:

  • Known neurological, psychiatric disorders, or co-morbid disease that would prevent completion of the study
  • Inadequate vision
  • Inadequate reading skills
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727909

Locations
United States, Florida
VA Medical Center, Bay Pines
Bay Pines, Florida, United States, 33708
United States, Tennessee
James H. Quillen VA Medical Center
Mountain Home, Tennessee, United States, 37684
VA Medical Center
Nashville, Tennessee, United States, 37212-2637
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Gene W. Bratt, PhD MA BA Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00727909     History of Changes
Other Study ID Numbers: C6288-R
Study First Received: July 30, 2008
Last Updated: August 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hearing loss
Hearing Aids
Speech Perception
Persons with Hearing Impairment

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Hearing Loss
Deafness
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014